{"doc_desc":{"title":"Etude transversale sur les d\u00e9c\u00e8s li\u00e9s \u00e0 l\u2019usage abusif de substances psychoactives","idno":"FRESH-PEF73054-fr","producers":[{"name":"Michel MALLARET","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73054-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73054"},{"agency":"FReSH","code":"FRESH-PEF73054"}]},"title":"Etude transversale sur les d\u00e9c\u00e8s li\u00e9s \u00e0 l\u2019usage abusif de substances psychoactives","alternate_title":"DRAMES"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Michel;MALLARET","firstname":"Michel","lastname":"MALLARET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/041rhpw39","role":"organisation id"},{"title":"SIREN","uri":"263800302","role":"organisation id"}],"email":"pharmacodependance@chu-grenoble.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","PILabo":"Centre R\u00e9gional de Pharmacovigilance et d'information sur les m\u00e9dicaments. Grenoble","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/041rhpw39","role":"sponsor id"},{"title":"SIREN","uri":"263800302","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]},{"name":""}]},"distribution_statement":{"contact":[{"name":"Michel;MALLARET","lastname":"MALLARET","firstname":"Michel","type":"contact","email":"pharmacodependance@chu-grenoble.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/041rhpw39","role":"organisation id","title":"ROR"},{"uri":"263800302","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"pharmacodependance"},{"keyword":"d\u00e9c\u00e8s"},{"keyword":"substances psychoactives licites et illicites"},{"keyword":"m\u00e9dicaments"},{"keyword":"drogues"},{"keyword":"toxicologie"},{"keyword":"stup\u00e9fiants"},{"keyword":"psychoactive"}],"topics":[{"topic":"M\u00e9decine g\u00e9n\u00e9rale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4b9f8efb-68dd-45a1-b04c-d23d457d6898"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D058006"}]},{"topic":"Psychiatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Addictologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/42d645e0-f58d-40ed-9917-5b227ff41a92"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000073316"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Cette \u00e9tude a \u00e9t\u00e9 mise en place afin d\u2019obtenir les donn\u00e9es les plus exhaustives possibles sur les cas de d\u00e9c\u00e8s survenant lors d\u2019usage de substances psychoactives dans le cadre d\u2019abus ou de pharmacod\u00e9pendance. Elle doit permettre : - l\u2019identification des substances impliqu\u00e9es dans les d\u00e9c\u00e8s des personnes faisant un usage abusif de substances psychoactives, m\u00e9dicamenteuses ou non. - le recueil de donn\u00e9es quantitatives (dosages sanguins) sur les substances en cause. - l\u2019estimation plus pr\u00e9cise du nombre des d\u00e9c\u00e8s li\u00e9s \u00e0 la drogue en France en r\u00e9duisant la sous-notification de certains d\u00e9c\u00e8s d\u2019origine toxique, en particulier ceux survenant dans un cadre m\u00e9dico-l\u00e9gal et donc non d\u00e9clar\u00e9s aux autorit\u00e9s sanitaires pour raison de secret de l\u2019instruction.","abstract":"","coll_dates":[{"start":"2002-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Sont inclus dans DRAMES les d\u00e9c\u00e8s r\u00e9pondant \u00e0 la  d\u00e9finition A de l\u2019OEDT des d\u00e9c\u00e8s li\u00e9s \u00e0 la drogue  (psychose due \u00e0 la drogue, d\u00e9pendance, toxicomanie sans d\u00e9pendance, empoisonnement accidentel  caus\u00e9 par la prise d\u2019opiac\u00e9s (si ant\u00e9c\u00e9dent d\u2019abus), de coca\u00efne, de psychostimulants, de cannabis, d\u2019hallucinog\u00e8nes ou de traitements de substitution aux opiac\u00e9s) et pour lesquels des analyses toxicologiques ont \u00e9t\u00e9 r\u00e9alis\u00e9es par les toxicologues participant \u00e0 l\u2019\u00e9tude.  Les d\u00e9c\u00e8s dus \u00e0 un suicide (intoxication m\u00e9dicamenteuse volontaire), \u00e0 une intoxication accidentelle  chez l\u2019Enfant (non d\u00e9pendant), \u00e0 un accident mortel de la circulation li\u00e9s \u00e0 la prise d\u2019un de ces  produits, \u00e0 des dossiers mal document\u00e9s ne sont pas inclus dans DRAMES\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"['Sont inclus dans DRAMES les d\u00e9c\u00e8s r\u00e9pondant \u00e0 la d\u00e9finition A de l\u2019OEDT des d\u00e9c\u00e8s li\u00e9s \u00e0 la drogue (psychose due \u00e0 la drogue, d\u00e9pendance, toxicom anie sans d\u00e9pendance, empoisonnement accidentel caus\u00e9 par la prise d\u2019opiac\u00e9s (si ant\u00e9c\u00e9dent d\u2019abus ), de coca\u00efne, de psychost imulants, de cannabis, d\u2019hallucinog\u00e8nes ou de traitements de substituti on aux opiac\u00e9s) et pour lesquels des analyses toxicologiques ont \u00e9t\u00e9 r\u00e9alis\u00e9es par le s toxicologues participant \u00e0 l\u2019\u00e9tude']","committee":"","governance":""}],"other_quality_statement":"['Centre R\u00e9gional de Pharmacovigilance et d\\'information sur les m\u00e9dicaments']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"2011 (en 2012)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"29-04-2015","lastUpdatedAuto":null,"lastUpdatedManual":"12-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/ansm.sante.fr\/Declarer-un-effet-indesirable\/Pharmacodependance-Addictovigilance\/Outils-de-surveillance-et-d-evaluation-Resultats-d-enquetes\/%28offset%29\/3"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Le recueil des donn\u00e9es est effectu\u00e9 sur une fiche anonyme, remplie par le toxicologue expert","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"13 CEIP en France"},"dataTypes":{"clinicalDataDetails":"Le recueil des donn\u00e9es est effectu\u00e9 sur une fiche anonyme, remplie par le toxicologue expert. Les donn\u00e9es recueillies permettent de caract\u00e9riser les su jets, de d\u00e9crire les circonstances de d\u00e9couverte du corps","biologicalDataDetails":"le stade de l\u2019abus au moment du d\u00e9c\u00e8s, les r\u00e9sultats de l\u2019autopsie ainsi que l\u2019identification des substances incrimin\u00e9es et leur implication re spective, la quantification des substances retrouv\u00e9es dans les pr\u00e9l\u00e8vements biologiques,","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}